Re-Use of Diagnostic Reagent Solution Labels - Buffer Solutions for Internal Use

[rwp_kennedy]

Hello,

I work at a small ISO 9001 certified company that manufactures a variety of diagnostic reagents. A number of buffers (for internal use) are made by our manufacturing chemists every day that require a label to be affixed to the container which indicates the buffer's identity and unique lot number. It has come to my attention that several of the manufacturing chemists have become lazy and instead of creating a new buffer label when the same solution is made they are simply applying a GMP correction to the label on the container and indicating the new lot number of the buffer. I was always taught that this was a GMP no-no and that you should rip off the old label and create a new label from scratch. Does anyone know if there is a GMP regulations that speaks to this event or can corroborate that that replacing the old label is just industry standard? Thanks in advance for your assistance!

 

[GStough]

Hello,

I work at a small ISO 9001 certified company that manufactures a variety of diagnostic reagents. A number of buffers (for internal use) are made by our manufacturing chemists every day that require a label to be affixed to the container which indicates the buffer's identity and unique lot number. It has come to my attention that several of the manufacturing chemists have become lazy and instead of creating a new buffer label when the same solution is made they are simply applying a GMP correction to the label on the container and indicating the new lot number of the buffer. I was always taught that this was a GMP no-no and that you should rip off the old label and create a new label from scratch. Does anyone know if there is a GMP regulations that speaks to this event or can corroborate that that replacing the old label is just industry standard? Thanks in advance for your assistance!

FWIW....

21 CFR 820 Section 820.120: "Each manufacturer shall establish and maintain procedures to control labeling activities. (a) Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use..."

This is the closest thing I found when I did a quick search of the QSR...Hope this helps. The issue of legibility always comes into play when someone handwrites a correction, especially on a label, as the amount of space may be very limited.